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HANNAH LIPPITT: Hello,

and welcome to the Totally Clinical Podcast brought to you by Teckro. Totally Clinical is a deep dive into the freshest trends, big-time challenges, and most excellent triumphs of clinical trials. I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders, and, most importantly, the people benefiting from clinical research. So tune in, settle back, and don't touch that dial. It's time to get Totally Clinical.

Today, I'm speaking with Malia Lewin, global head of strategy at Teckro. Now, Malia has been in the oncology space for 20 years, starting her career in Washington on access and reimbursement for the early molecular antibodies for breast cancer and other cancer types. During this podcast, Malia discusses how oncology trials can especially benefit from Teckro’s platform, why sponsors and sites need to prioritize innovation when it comes to new tools, the future of oncology trials and more. Welcome, Malia. Could you start by expanding on why oncology is a major focus for Teckro?

MALIA LEWIN: Oncology is a major

focus for Teckro because it is the area of pharmaceutical drug development with the greatest need for speed, efficiency and agility. Oncology accounts for about 35% of all pipeline products currently in development. Close to 80% of these new agents are aimed at targets with either an existing marketed therapy or three to four competitors in therapies and development.

Oncology trials are also more complex, so there's high science with cutting edge treatments like CAR T, but we also have things like combination therapies and just an overall rapidly evolving standard of care, which creates a lot of complexity in these studies. We also have a situation where oncology drug development tends to be the most expensive, so any efficiency that we can build into the trial process really is quite meaningful for sponsors.

HANNAH LIPPITT: So

why are oncology trials especially challenging?

MALIA LEWIN: There are a number of different things that make oncology trials challenging from the overall cost it takes to run a clinical trial, they tend to be longer than most other clinical studies, you have patients who are often quite ill – we're dealing with a life-threatening disease in oncology. It's actually, if you think about it, not just one disease, it's about 20 different diseases. So, you have a really complex patient population.

And in terms of the studies themselves and the agents themselves, they're really quite sophisticated. So you have things that are more cutting edge like CAR T-cell therapies, but you also have frequently the use of a biomarker together with the treatment as well as combination therapies, and all of these added nuances really create a lot of complexity and trial designs, as well as in the protocols. So you have a lot of the need at the site level to really understand exactly what's going on in each study to be able to differentiate among them, and a lot of the time the sites are running many oncology studies at the same time.

So also just differentiating between and among them, it becomes really important to have access to information and communication tools to be able to get your questions answered when you have patients in front of you. And so the old ways of operating where information is either trapped inside of static documents, either in paper form or PDFs, or sitting on a centralized computer far away from where a patient is being seen, really don't help as much in a complex trial – like an oncology trial – where you have a patient in front of you and you really need to get to the information you need in terms of not only inclusion and exclusion criteria when you're enrolling a potential patient, but also when a patient's in the office for a visit, understanding exactly what's on the schedule and any information really that you might need from that protocol.

HANNAH LIPPITT: And

oncology trials also have a lower success rate, don't they?

MALIA LEWIN: One of the many things that's interesting about oncology trials is just how high the risk of failure is. So there are a number of different ways to measure it. The composite success rate, which tends to measure the likelihood of a product entering Phase I to reach market, has remained roughly the same since 2013 for oncology products and varies between 7% to 8%, which is pretty small if you think about the number, the overall volume of trials, the fact that only 7% to 8% of targets that enter Phase I actually reach market, it's pretty small. We also know that these trial phases are longer than in other therapeutic areas, which is interesting. So the average duration of oncology trial is about 3.2 years, compared with about 1.8 years for other types of trials. And the reason that's significant is because the longer a trial is, the higher the chance you have of patients dropping out of that trial. So for all of those reasons, there's a big risk of failure.

We also have the challenge around finding the right patients for these trials. So often, the inclusion and exclusion criteria are... well, the inclusion criteria are quite narrow and the exclusion criteria are quite broad, and so actually finding the sort of Goldilocks patients, if you will, that fit the criteria for these trials can be very, very difficult. And so that can also extend the length. I mean, that that's probably one of the largest factors driving the overall length of an oncology study.

HANNAH LIPPITT: Oncology

trials are some of the more complex trials, aren't they?

MALIA LEWIN: One measurement I saw recently was that clinical trial complexity in oncology has increased about 11% from 2014 to 2018 and then 22% if you look at a broader scope of the year's 2010 to 2018. So, what this is really being driven by is an increase in the number of endpoints and eligibility criteria. It's also considering the fact that there are fewer countries and fewer sites that tend to be included. And so it's a really interesting environment that we're looking at in terms of trial complexity and how that's existing in the oncology space, specifically.

HANNAH LIPPITT:

Advanced analytics is really changing the game when it comes to efficiency and better outcomes during clinical trials. This is especially the case for oncology trials. Could you explain the benefits of advanced analytics?

HANNAH LIPPITT: I was reading a McKinsey article recently, and in the article, the author talked about the incredible promise of advanced analytics and oncology. And when we think about the use of data and analytical models in asset discovery, it's exciting to think about what we can do if we carry through this appetite for innovation to the operation of clinical trials. So, when we think about the data that can be collected and leveraged through the course of a trial that can really assist sponsors in the agile navigation of a complex oncology study, you just realize that solutions like Teckro are a must-have.

So, you know, investigators need to access protocol information at the point of care, and they need answers to questions while the patient is still in front of them. Sponsors can use this information to help other sites navigate the trial more effectively and efficiently. And this data can also serve the sponsor and the site with future planning and execution of trials. This is really a novel data set that we haven't really had access to before in not just in the oncology space across therapeutic areas, but it can really be leveraged in combination with other data sets.

One example that I've been thinking a lot about recently is around the current way we navigate the world navigation apps, Google Maps... like... Waze. These types of applications really help us get where we're going faster and with greater efficiency because it isn't like the old days of maps or even MapQuest where you are looking at a map and you have one way of getting somewhere. Right now, we're able to navigate the world using real time information that's in our handheld device. So, I know if I'm leaving to go someplace and there's an accident or a parade or construction along the way, I have apps that are going to notify me and help me navigate around those obstacles. And what we want is to create the same thing for the clinical trial environment. So that people are no longer beholden to static documents or capture of information that isn't really serving them in a real time. We want to provide sites and sponsors with tools that will allow them to communicate in the course of a trial and really help to improve it as it's happening and as it's ongoing. And those types of improvements will lead to better outcomes for the research and ultimately better outcomes for patients.

HANNAH LIPPITT: Why do you

believe that there is some reluctance to adopt new tools on the part of sponsors and sites?

MALIA LEWIN: You know, even the most innovative companies can struggle with getting new tools adopted as people of science. Our industry and all of the stakeholders in it tend to want to deploy tools that are well established and proven, but this orthodoxy is really at odds with the spirit of innovation itself. So with Teckro of course, we're providing training to all of the different stakeholders who use Teckro.

But I think the other important piece of it is that we're also engaging each stakeholder as a true partner, right? So, what we want to do is help overcome this reluctance, right? And adapt for what we understand to be a very fast pace in the oncology space. We know that the sites need to move with a certain amount of agility and efficiency. Their objective is patient care. So we really want to be with the sites to work and work closely with them to make sure that our technology and our solutions are matching up with what they need as a site and also what they expect as consumers.

So if you think about it, when we're looking for answers in the course of our regular lives as consumers, we're used to being able to take out a handheld device and find the information that we need. We are now no longer going and rifling through a paper file. We're no longer going back to our desktop and searching for a PDF. We expect things to be a certain way and so we're really working with sites to combine what we know they want as users with what they need as sites.

And we're also working with our sponsors to make sure that they're ready for this type of innovation and to help them understand the treasure trove of information that can be available from this new data set that they're not used to seeing before. So really, having access to the search data that we provide a lot of the tracking that we're doing and the deep linking topically really provides a very rich data set that we hope is compelling enough to help overcome some of the barriers that sponsors can sometimes have with the adoption of new tools.

HANNAH LIPPITT: What

are your thoughts on the future of oncology trials?

MALIA LEWIN: So, in terms of the future for oncology clinical trials, I think it goes back to where I started in the beginning, which is just with my own personal experience. And when I first started in oncology, fewer than 5% of cancer patients were participating in clinical research. And now I think, depending on who you ask, we're hovering just under 10% and I still believe clinical research trials offer optimal patient care and that more and more people should be participating in them.

We also need people to be in clinical trials in order to continue to drive discovery. We're not done with cancer yet. We've made a lot of progress, but there are a lot of people, there are a lot of lives at risk and there's a lot of opportunity for life-changing and lifesaving therapies, and we need to get more people engaged. I don't think that’s just patients. In order to do this, in order to engage patients, we need to really engage the entire health care ecosystem.

And when I think about Teckro and what's exciting about it is the heart of clinical research is really the protocol. And what we've been able to do is bring that back to life and make it a hub of communication for all stakeholders. And I think that that's a major advance but I also think we need to continue to build on that and to build outward and bring people into the fold into clinical research that might not currently be there.

I think there's a lot of talk about decentralized trials, and certainly that's part of it, thinking to continue to expand and bring more people to the table and break down some of the traditional silos around the paradigm of clinical research that doesn't necessarily include everyone. There are many, many roles to play here, whether it's non-traditional sites referring patients into clinical research studies, figuring out how to engage and empower remote nurses with tools that they might need in the modern era as they're working on trials and taking them outside the boundaries of traditional labs, traditional clinics. There's a lot of opportunity there, and I think we're just going to continue to see this ecosystem broaden and develop and support a much larger universe when it comes to clinical research studies.

HANNAH LIPPITT:

You mentioned that decentralized trials are talked about a lot, but that really the expansion of the ecosystem is what will make the difference. Physicians are a key part of this, aren't they?

MALIA LEWIN: Traditionally, the paradigm is that there are physicians who do research and there are physicians who see patients and there are physicians who teach. Sometimes you see people who do a little bit of everything, but I think that really we need to engage far more, much larger group of physicians, nurses and others in the clinical research paradigm if we're going to achieve what we'd like to achieve in oncology.

HANNAH LIPPITT: Thank you Malia

for joining me on the podcast today and explaining more about oncology trials and Teckro. And that's your dose of Totally Clinical. For all the listeners out there, you can follow Teckro on Twitter – the handle is @TeckroOfficial – LinkedIn, and Facebook, and subscribe to our YouTube channel. And, of course, download the Totally Clinical Podcast on Apple, Spotify, and Google. See you on your next visit and remember to bring your friends. Thanks for listening. Goodbye.

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